Postoperative Outcomes of Natural Orifice Specimen Extraction (NOSE) in Low Rectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Surgical Site Infections (SSI)
研究概览
简要总结
This study aims to compare the postoperative outcomes of low rectal cancer patients who underwent surgery with Natural Orifice Specimen Extraction (NOSE) versus traditional Pfannenstiel extraction.
详细描述
Natural Orifice Specimen Extraction (NOSE) in colorectal surgery allows the extraction of the surgical specimen through the anal orifice. Several studies demonstrated improved postoperative pain, bowel movements, patient-reported cosmetic satisfaction, and psychological wellbeing after NOSE compared with traditional Pfannenstiel extraction. However, most of these studies focused on colon surgery. The aim of this retrospective propensity score matched study is to investigate the postoperative outcomes of NOSE in low rectal cancer surgery, classified according to the English National Low Rectal Cancer Development Programme (LOREC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing low anterior resection with Total Mesorectal Excision (TME) for low rectal cancer between January 2017 and January 2023
- •Patients with rectal cancer classified as "low" according to the English National Low Rectal Cancer Development Programme (LOREC)
排除标准
- •Patients undergoing non-restorative procedures
- •Patients undergoing immediate or delayed handsewn coloanal anastomosis
- •Patients undergoing planned open surgery or unplanned conversion from minimally invasive to open surgery
- •Patients with a concomitant diagnosis of Inflammatory Bowel Disease (IBD)
结局指标
主要结局
Surgical Site Infections (SSI)
时间窗: 30 days after surgery
Rate difference of 30-day Surgical Site Infections (SSI)- defined according to the definition of the Center for Disease Control and Prevention (CDC) \[Ref\]- between the study cohorts.
次要结局
- Incisional hernia(6 months after surgery)
- Postoperative pain(72 hours after surgery)
- Postoperative ileus(30 days after surgery)
- Overall postoperative complications(30 days after surgery)
- Opioid rescue(From the date of surgery to the date of discharge)